Manager – Qualification & Validation (OSD)

Job Purpose

To lead and manage qualification, validation, and requalification activities for equipment, facilities, utilities, and manufacturing processes, ensuring compliance with cGMP, regulatory requirements, and data integrity standards.

Key Responsibilities

• Ensure cGMP, Data Integrity, and regulatory compliance in all qualification and validation activities.
• Prepare, review, implement, and maintain the Validation Master Plan (VMP).
• Plan, execute, monitor, and review qualification/requalification of equipment, instruments, facilities, HVAC systems, water systems, compressed air systems, and utilities.
• Lead facility qualification, utility qualification, and temperature mapping activities.
• Prepare, review, and approve Process Validation, Cleaning Validation, Hold Time Study, and Process Verification protocols and reports.
• Coordinate execution of validation activities, including sampling, monitoring, and documentation.
• Track qualification and validation schedules and ensure timely compliance.
• Review qualification/validation-related SOPs, protocols, reports, certificates, manuals, and technical documents.
• Support audits, regulatory inspections, and timely closure of observations related to qualification and validation.
• Review environmental monitoring and BMS data to ensure compliance.
• Investigate and support closure of deviations, incidents, CAPAs, and change controls related to qualification and validation activities.
• Coordinate with Production, Engineering, QC, QA, and external agencies for execution of qualification and validation programs.
• Ensure proper maintenance, control, and archival of qualification and validation records.
• Provide training on qualification, validation, and applicable quality systems.
• Adhere to EHS requirements, report unsafe conditions, and participate in safety initiatives.

Qualification & Experience

• B.Pharm / M.Pharm / B.Sc / M.Sc or equivalent.
• 814 years of experience in Qualification & Validation within a regulated pharmaceutical manufacturing facility, preferably OSD.

Key Competencies

• Qualification & Validation
• Process & Cleaning Validation
• Utility & Facility Qualification
• Regulatory Compliance
• Data Integrity
• Audit & Inspection Readiness
• Documentation & Technical Review
• Cross-functional Coordination